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Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: LCS12 (Drug); LCS16 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Clinical Details

Official title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 ”g/24h and 16 ”g/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16”g/24h Dose Group (LCS16 Arm) up to 5 Years

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pearl Index

Secondary outcome:

Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1

Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2

Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3

Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4

Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12

Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1

Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2

Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3

Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4

Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12

Number of Participants With/Without Ovulation - Year 1

Number of Participants With/Without Ovulation - Year 2

Number of Participants With/Without Ovulation - Year 3

Average Total Cervical Score - Year 1

Average Total Cervical Score - Year 2

Average Total Cervical Score - Year 3

Classification of Endometrium - Year 1

Classification of Endometrium - Year 2

Classification of Endometrium - Year 3 / End of Study

Degree of User Overall Satisfaction With Study Treatment

Number of Participants With Partial or Total Expulsion

Detailed description: Drop out-rate will be covered in Participant flow section.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age between 18 and 35 years (inclusive), in good general health and requesting

contraception.

- Has regular menstrual cycles (length of cycle 21-35 days) (i. e., endogenous cyclicity

without hormonal contraceptive use). Exclusion Criteria:

- Known or suspected pregnancy or is lactating.

- History of ectopic pregnancies.

- Any genital infection (until successfully treated).

- Abnormal uterine bleeding of unknown origin.

Locations and Contacts

Quebec G1S 2L6, Canada

Quebec G1V 4X7, Canada

Santiago de Chile, Chile

Santiago, Chile

Espoo 02100, Finland

Helsinki 00100, Finland

Joensuu 80100, Finland

Kotka 48100, Finland

Kuopio 70100, Finland

Lahti 15110, Finland

Oulu 90220, Finland

Oulu 90570, Finland

Oulu 90100, Finland

Tampere 33100, Finland

Turku 20540, Finland

Turku 20100, Finland

Turku 20520, Finland

COMPIEGNE cedex 60204, France

Grenoble 38043, France

Le Chesnay 78150, France

Lille 59037, France

Nimes 30029, France

Quetigny 21800, France

REIMS Cedex 51092, France

Roanne 42300, France

Bekescsaba 5600, Hungary

Budapest 1116, Hungary

Eger 3300, Hungary

Esztergom 2500, Hungary

Kecskemet 6000, Hungary

Nyiregyhaza 4400, Hungary

Szentes 6600, Hungary

MĂ©xico, D. F. 06700, Mexico

MĂ©xico, D.F. 11000, Mexico

MĂ©xico, D.F. 06720, Mexico

Alkmaar 1817 MS, Netherlands

Den Haag 2545 CH, Netherlands

Eindhoven 5623 EJ, Netherlands

Heerlen 6419 PC, Netherlands

Helmond 5707 HA, Netherlands

Hoofddorp 2134 TM, Netherlands

Nijmegen 6532 SZ, Netherlands

Rotterdam 3079 DZ, Netherlands

Utrecht 3582 KE, Netherlands

Elverum 2403, Norway

Kolbotn 1411, Norway

Larvik 3264, Norway

Oslo 0364, Norway

Trondheim 7012, Norway

Göteborg 416 64, Sweden

Huddinge 14186, Sweden

LuleÄ 972 33, Sweden

Malmö 217 44, Sweden

Norrköping 602 22, Sweden

Stockholm 118 83, Sweden

Stockholm 171 76, Sweden

Stockholm 182 88, Sweden

Umea 90185, Sweden

Uppsala 75185, Sweden

Örebro 70185, Sweden

Mobile, Alabama 36608, United States

Calgary, Alberta T2N 4L7, Canada

Glendale, Arizona 85304, United States

Phoenix, Arizona 85032, United States

Tucson, Arizona 85712, United States

Lanus Oeste, Buenos Aires 1824, Argentina

San Isidro, Buenos Aires B1642CLN, Argentina

Carmichael, California 95608, United States

Pacific Palisades, California 90272, United States

San Diego, California 92123, United States

San Diego, California 92108, United States

San Diego, California 92103, United States

San Diego, California 92130, United States

Torrance, California 90502, United States

Buenos Aires, Ciudad Auton. de Buenos Aires C1425ASQ, Argentina

TorreĂłn, Coahuila 27000, Mexico

Denver, Colorado 80218, United States

Littleton, Colorado 80128, United States

Szeged, Csongrad 6720, Hungary

Boyton Beach, Florida 33472, United States

Jacksonville, Florida 32216, United States

Miami, Florida 33186, United States

West Palm Beach, Florida 33409, United States

Atlanta, Georgia 30328, United States

Decatur, Georgia 30034, United States

Boise, Idaho 83702, United States

Idaho Falls, Idaho 83404, United States

Chicago, Illinois 60612, United States

Evansville, Indiana 47714, United States

South Bend, Indiana 46601, United States

Marrero, Louisiana 70072, United States

Winnipeg, Manitoba R3A 1M3, Canada

Winnipeg, Manitoba R3E 3P4, Canada

Boston, Massachusetts 02118, United States

Kalamazoo, Michigan 49009, United States

Chaska, Minnesota 55318, United States

Chesterfield, Missouri 63017, United States

Lincoln, Nebraska 68510, United States

Las Vegas, Nevada 89106, United States

Las Vegas, Nevada 89128, United States

Las Vegas, Nevada 89135, United States

Moorestown, New Jersey 08057, United States

New Brunswick, New Jersey 08903-2685, United States

Albuquerque, New Mexico 87102, United States

New York, New York 10032, United States

New Bern, North Carolina 28562, United States

Winston-Salem, North Carolina 27103, United States

Monterrey, Nuevo Leon 64460, Mexico

Cincinnati, Ohio 45267, United States

Columbus, Ohio 43213, United States

Kingston, Ontario K7L 2V7, Canada

London, Ontario N6A 4G5, Canada

Waterloo, Ontario N2L 6H6, Canada

Medford, Oregon 97504, United States

Portland, Oregon 97239, United States

Jenkintown, Pennsylvania 19046, United States

Philadelphia, Pennsylvania 19114, United States

Pittsburgh, Pennsylvania 15206, United States

Pittsburgh, Pennsylvania 15213-3180, United States

Montreal, Quebec H1T 1P6, Canada

Montreal, Quebec H4P 2S4, Canada

Shawinigan, Quebec G9N 2H6, Canada

Sherbrooke, Quebec J1H 4J6, Canada

Rosario, Santa Fe 2000, Argentina

Saskatoon, Saskatchewan S7H 5M3, Canada

Hermosillo, Sonora 83100, Mexico

Columbia, South Carolina 29201, United States

Chattanooga, Tennessee 37404, United States

Memphis, Tennessee 38119, United States

Nashville, Tennessee 37203, United States

Austin, Texas 78748, United States

Houston, Texas 77030, United States

Houston, Texas 77054, United States

Norfolk, Virginia 23507, United States

Seattle, Washington 98105, United States

Spokane, Washington 99207, United States

Additional Information

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Starting date: August 2007
Last updated: August 5, 2013

Page last updated: August 23, 2015

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